The U.S. Food and Drug Administration (FDA) has announced that it will resume domestic inspections of regulated facilities during the week of July 20, 2020, after pausing in March due to COVID-19. "To arm our investigators with the most reliable and accurate information, the FDA has developed a rating system to assist us in determining when and where it is safest to conduct prioritized domestic inspections," the agency states. "The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data. We are also making the Advisory Level data available to our state partners who carry out inspections of FDA-regulated entities on the agency’s behalf under contract." The agency also announced that the inspections will be pre-announced. "The FDA has also determined that, for the foreseeable future, prioritized domestic inspections will be pre-announced…
Category Archives Issue
The U.S. Food and Drug Administration (FDA) has released a blueprint of plans to implement the Food Safety Modernization Act and a hub for the New Era of Smarter Food Safety. The blueprint focuses on four elements: (i) tech-enabled traceability; (ii) smarter tools and approaches for prevention and outbreak response; (iii) new business models and retail modernization; and (iv) food safety culture. "This document represents the thinking of FDA food safety experts, consumers, the food industry, technology firms, federal and state regulatory partners, our regulatory counterparts in other nations, and academia," the blueprint states. "Together, we envision a framework that will enable food to be traced to its source in seconds and will utilize new data analytical techniques to strengthen prevention of foodborne illnesses, alerting consumers in real time before contaminated or misbranded foods are consumed. We envision a framework in which education, communication, and democratization of data will enable…
The U.S. Department of Agriculture (USDA) has issued a response to the Physicians Committee for Responsible Medicine's petition urging the agency to require meat and poultry processing plants to publish information about COVID-19 testing and infection rates at their facilities and to include on their product labels the statement "Warning: Workers in U.S. meat and poultry processing facilities have been sickened or killed by the SARS-CoV-2 virus, and this product has not been certified virus-free.” USDA's Food Safety and Inspection Service states that it does not have the authority to require facilities to report on the health information of their workers. The agency's response further notes that the proposed warning statement "is misleading because it inaccurately implies that meat and poultry products that have not been 'certified as virus-free' may transmit COVID-19 or are somehow unsafe. As discussed above, public health and food safety experts have found no evidence to…
A California court has reportedly ruled that Californians can buy foie gras from out-of-state sellers and have it delivered within the state to avoid the state's ban on sales or gifts of foie gras. The ruling applies only to individual purchasers, as restaurants and retailers are still prohibited from selling foie gras, according to the Associated Press. “There is no principled way to distinguish between foie gras purchased out of state and transported into California by the purchaser and that which is delivered by a third party,” the court reportedly held.
The U.S. Court of Appeals for the Second Circuit has sided with an objector to a class settlement in a lawsuit alleging that Barilla USA pasta boxes contained too much slack fill. Berni v. Barilla S.p.A., No. 19-1921 (2nd Cir., entered July 8, 2020). The lawsuit asserts that Barilla reduced the amount of pasta in its box packaging but retained the same size of box, allegedly misleading consumers. The parties reached a settlement that included payments to class counsel and the named representative along with an agreement to update the packaging to include a “fill line” to indicate how much pasta the box contains. A class member objected to the settlement, arguing that the only relief the class received was injunctive relief, and a class of past purchasers could not be certified for injunctive relief. The district court rejected the objector’s assertion, but the Second Circuit disagreed with the lower…
The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due diligence program to review and approve foreign suppliers of imported food. In May 2020, FDA placed two companies on Import Alert 99-41, which is essentially an import ban where an importer cannot import the food until they implement an appropriate FSVP to FDA’s satisfaction. This is not the first time FDA placed a company on Import Alert 99-41. However, the previous import alert listing concerned a company that imported food associated with a recall and foodborne illnesses. In this instance, there is no indication that the food caused any food illnesses or was otherwise non-compliant; rather, it appears that the only issue was the importers failed to comply with the FSVP requirement. This inherently changes the tenor of an FSVP inspection because they now…
The European Commission has announced the adoption of strategies to support biodiversity and “transition to a sustainable EU food system that safeguards food security and ensures access to healthy diets sourced from a healthy planet.” “The coronavirus crisis has underlined the importance of a robust and resilient food system that functions in all circumstances, and is capable of ensuring access to a sufficient supply of affordable food for citizens,” a question-and-answer resource on the program stated. “It has also made us acutely aware of the interrelations between our health, ecosystems, supply chains, consumption patterns and planetary boundaries.” The program’s goals include reduction of chemical pesticides, preservation of soil nutrients, reduction in sales of antimicrobials for farmed animals and aquaculture, and an increase in organic farming by 2030. The program will also include the proposal of mandatory front-of-packaging nutrition labeling and efforts to reduce food waste.
U.S. Rep. Earl Blumenauer (D-Ore.) has introduced The Real Economic Support That Acknowledges Unique Restaurant Assistance Needed to Survive Act of 2020 (RESTAURANTS Act). The proposed bill would create a $120 billion “restaurant stabilization grant program designed to help independent restaurants deal with the long-term structural challenges facing the industry due to COVID-19 and ensure they can reemploy 11 million workers,” according to Blumenauer’s May 20, 2020, press release. The program, which would be administered by the Department of the Treasury, would provide grants sufficient "to cover the difference between revenues from 2019 and projected revenues through 2020, with a maximum grant of $10 million.”
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has released a final rule updating regulations on genetically modified organisms (GMOs). The rule adjusts the regulatory process for specific GMOs created to combat plant pests that pose no increased plant pest risk than conventionally bred plants.
The U.S. Food and Drug Administration (FDA) has published the results of its investigation into an outbreak of E. coli in November and December 2019 caused by romaine lettuce and other leafy greens from the Salinas Valley area of California. FDA found that nearby land used for cattle grazing was the most likely contributing factor associated with three outbreaks that stemmed from three distinctly different strains of E. coli.
